K811688 is an FDA 510(k) clearance for the TUNGSTEN SYRINGE SHIELD. This device is classified as a Holder, Syringe, Lead (Class I - General Controls, product code IWR).
Submitted by Medi-Physics Inc. Dba Nycomed Amersham Imaging (Mchenry, US). The FDA issued a Cleared decision on July 2, 1981, 17 days after receiving the submission on June 15, 1981.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500.
| 510(k) Number | K811688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1981 |
| Decision Date | July 02, 1981 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IWR — Holder, Syringe, Lead |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.6500 |